Certain diagnostic and therapeutic procedures require access to an internal portion of a patient's body using a catheter. Catheters have been used in cardiovascular, urological, gastrointestinal, neurovascular and ophthalmic applications. Example gastrointestinal uses of catheters include the treatment of intussusceptions, inversion of one portion of the intestine within another. Intussusception is the most common cause of intestinal obstruction in children and occurs when the bowel telescopes into itself. It is the main cause of intestinal obstruction in infants with 80% to 90% of the events occurring in children ages three months to three years.
While the cause of intussusception is unknown, there are theories of why it occurs. Most patients are diagnosed with intussusception after they have had a bout of gastroenteritis, also known as stomach flu. Gastrointestinal infections can cause swelling of the lymph tissue that lines the intestinal wall, which can pull one part of the intestine into the other. Blood flow through the intestine is decreased thereby causing swelling and inflammation. The condition can progress from intestinal obstruction to necrosis of a segment of the intestine. The swelling can lead to perforation and generalized abdominal infection. Shock and dehydration can occur rapidly.
While surgery is the main treatment method for intussusception, barium or air enema reduction can be used as a less invasive treatment procedure. In general, the air procedure tends to be more efficient and quicker than using barium. During the air enema procedure, a catheter is placed in the patient's rectum. Once the catheter is in place, a seal must be created to substantially stop the leakage of air out of the rectum. The external portion of the catheter is attached to a pneumatic device which allows pressure regulation during the procedure. During treatment, as air and pressure within the bowel increase, the intussusception is reduced. Once reduced, the catheter is removed.
In order to achieve optimal results, a seal between the catheter and the rectum must be achieved to prevent leakage of airflow around the catheter. In most procedures it is very difficult, if not impossible, to achieve a complete seal. Current techniques to achieve a seal include holding or taping the buttocks together in an effort to compress the rectum and the fleshy buttocks to prevent air leakage. These methods are not only painful to the patient, but they can also be insufficient to achieve the desired seal. Failure to accomplish an effective seal will not only compromise the outcome of the procedure but will increase the procedure time and result in suboptimal outcome. In some cases, this suboptimal outcome requires surgery to correct the problem.
Accordingly, there remains a need in the art to provide safe and effective apparatus that maintains a seal between a catheter and a body orifice that can be used, for example, during non-surgical methods of treating intussusceptions using either air or barium enema reduction techniques.